MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

Model Number	C2PIVL4012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a lesion in the ostium of the right coronary artery (rca).It was reported that during the third pulse cycle the patient developed ventricular fibrillation (vf) requiring cardioversion.After stabilization, the team elected to stop ivl and switched to a scoring balloon and non-compliant (nc) balloon, resulting in a sub-optimal outcome.The patient is currently doing well.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.Based on the reported information, the cause of the ventricular fibrillation and subsequent cardioversion for arrhythmia could not be determined.There was no reported ivl catheter malfunction.Shockwave has warnings and precautions in the device instructions or use related to these types of events which are referenced below.Ivl generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients.In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities.Monitoring of the electrocardiographic rhythm and continuous arterial pressure during ivl treatment is required.In the event of clinically significant hemodynamic effects, temporarily cease delivery of ivl therapy.In the cad iii study, there were no serious adverse events associated with ivl-induced capture including arrhythmia.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lot does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER
• Common Device Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): SHOCKWAVE MEDICAL, INC; 5403 betsy ross drive; santa clara 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 23563451
• Report Number: 3015053858-2025-00138
• Device Sequence Number: 10160563
• Product Code: QMG
• UDI-Device Identifier: 00195451000034
• UDI-Public: (01)00195451000034(17)270731(10)12D250715A
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P200039/S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C2PIVL4012
• Device Catalogue Number: C2PIVL4012
• Device Lot Number: 12D250715A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRUG ELUTING BALLOON (DEB) - UNKNOWN MANUFACTURER.; MAGMARIS (A MAGNESIUM-BASED BIORESORBABLE SCAFFOLD.; NON-COMPLIANT BALLOON - MFG UNKNOWN.; STENT - UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female